Mother loses baby after being given 'abortion' drug to induce labour

A leading teaching hospital is giving pregnant women an unlicensed abortion
drug, Misoprostol, to induce labour despite being sued over the death of a
baby.

Roberto Figus and Anne Willicombe with their daughter Sofia shortly before she diedPhoto: PAUL GROVER

By Robert Mendick and Laura Donnelly

8:45PM GMT 16 Jan 2010

The death of Sofia Figus three days after she was born was caused by a lack of oxygen to the brain during a difficult birth. Her mother Anne Willicombe, 39, a university lecturer, was 12 days overdue when she was prescribed Misoprostol – a drug widely used in abortion clinics – to bring on contractions.

Mrs Willicombe and her husband Roberto Figus are now suing the Homerton Hospital in east London for failing to monitor the baby in the womb and follow correct safety procedures which should have been put in place as a result of being given the drug. A midwife was sacked over the death.

Misoprostol is only licensed in this country for the treatment of stomach ulcers. Under official guidelines from the National Institute for Health and Clinical Excellence [NICE], it should not be used to induce labour unless as part of a clinical trial.

Mrs Willicombe told The Sunday Telegraph: "Losing your child is a parent's worst nightmare. It has devastating consequences for the rest of your life. We miss Sofia every minute of every day, but in this case it isn't just the fact of losing our child. For me it is all the other things like finding out the drugs could have been a factor, things about my care. This is all so difficult to come to terms with on top of losing our daughter."

Sofia, who would have been two next month, was perfectly healthy in the womb and her death has devastated her parents who have struggled to conceive again. Mrs Willicombe suffered a miscarriage last year – possibly, she believes, due to the stress.

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Hundreds of women have been given Misoprostol during labour in clinical trials in more than a dozen NHS hospitals across Britain. It is thought that only the Homerton regularly uses the drug, which is cheaper than other methods to induce birth, for those women who are not taking part in research.

Belinda Phipps, chief executive of the National Childbirth Trust, said she was "absolutely incredulous" that any hospital would give the drug to women outside of clinical trials.

She said: "This drug is not licensed for use in labour, and the NICE guidance is categorical on that point. In this country, misoprostol should only be used in labour if the baby is already dead, or after the birth, because otherwise the risks are simply too great."

Mrs Willicombe was not informed the drug was only recommended for use in clinical trials – and nor was she told that she was taking part in any trial.

"I just remember them being very reassuring and saying this drug is fine," said Mrs Willicombe. Mr Figus, 41, a management consultant, added: "They said they had been using Misoprostol for a while. They said it was the newest thing but they had been using it for a while. They never said anything about a clinical trial and we didn't sign anything."

Despite being given two doses of Misoprostol, Mrs Willicombe, who lives in Hackney in east London, was not properly monitored and was treated in a room unsuitable for what should have then been classified a high-risk birth.

Within 10 minutes of being given the drug on 11 February 2008, Mrs Willicombe said her waters broke – almost certainly naturally because it was too soon for the Misoprostol to take effect. About four hours later, she was given a second dose leading to contractions which then became more frequent and more violent.

"This was my first child and I didn't know what to expect," said Mrs Willicombe, "We had been waiting pretty much all day for something to happen and the speed in the end took me by surprise."

The mother-to-be was moved from the maternity ward to the delivery suite but then placed in a room, she says, without proper monitoring equipment. With only the midwife to check on her – and seemingly unable to use what equipment there was to monitor the baby's heartbeat – Sofia got into difficulties. The midwife then ordered Mr Figus to hit the alarm button. A team of doctors raced in to deliver the baby, the first time Ms Willicombe realised her dream of a first child was turning into her worst nightmare.

"She just came out blue and lifeless," recalled Ms Willicombe, "She was completely floppy. They held her up very briefly for us to see her and then took her away to resuscitate her. After nine minutes she started breathing but by then she had suffered severe brain damage due to a lack of oxygen. The doctors told us it was not a question of if she dies but when, so we agreed to take her off the ventilator. Three days later she died."

Their midwife, Juliet Osammor, was later sacked by the Homerton. In July regulators said she should not work unsupervised without further training although she is believed to still be working within the NHS in London.

At an inquest last month, a coroner in east London concluded Sofia had died of natural causes as a result of neglect.

Their lawyer Robert Antrobus, head of clinical negligence at Foot Anstey Solicitors, said: "It appears clear that Mrs Willicombe received substandard monitoring during her labour with Sofia. This substandard monitoring also needs to be put in to the context of the use of an unlicensed drug which is known to have the side effect of uterine hyperstimulation. It appears that Sofia's death could have been avoided, had the monitoring been appropriate."

Guidelines on Misoprostol issued by NICE state: "It is not licensed in the UK for obstetric use and the safety aspects have not been fully evaluated."

The drug is also used in abortion clinics and to speed the removal of the foetus following miscarriages. NICE guidance supports the use of the drug to prevent haemorrhage after birth.

A global study led by British researchers found there was not enough evidence supporting the drug's safety to warrant its use during labour without more research.

A hospital spokesman said the Homerton had carried out a trial published in 2008 which found that women preferred the Misoprostol tablets, which are taken orally, to the vaginal prostaglandin gels in common use in the NHS. Pregnant women would normally be offered Misoprostol only if their waters had broken and labour was not progressing, he said.

The spokesman said: "The risk of not inducing after 24 hours of rupture is neonatal infection and death of mother and/or baby."

He confirmed that women were still being given Misoprostol.

The spokesman added: "In the case of baby Sofia, it was not the drug which led to complications for her mother, but rather the failure of a midwife to provide proper supervision during labour as instructed by a clinician. That midwife has subsequently been dismissed by the Trust."